Epysqli

البلد: الاتحاد الأوروبي

اللغة: الإنجليزية

المصدر: EMA (European Medicines Agency)

العنصر النشط:

Eculizumab

متاح من:

Samsung Bioepis NL B.V.

ATC رمز:

L04AA25

المجموعة العلاجية:

Immunosuppressants

المجال العلاجي:

Hemoglobinuria, Paroxysmal

الخصائص العلاجية:

Epysqli is indicated in adults and children for the treatment of Paroxysmal nocturnal haemoglobinuria (PNH).Evidence of clinical benefit is demonstrated in patients with haemolysis with clinical symptom(s) indicative of high disease activity, regardless of transfusion history.

الوضع إذن:

Authorised

تاريخ الترخيص:

2023-05-26

نشرة المعلومات

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPYSQLI 300 MG CONCENTRATE FOR SOLUTION FOR INFUSION
eculizumab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Epysqli is and what it is used for
2.
What you need to know before you use Epysqli
3.
How to use Epysqli
4.
Possible side effects
5.
How to store Epysqli
6.
Contents of the pack and other information
1.
WHAT EPYSQLI IS AND WHAT IT IS USED FOR
WHAT IS EPYSQLI
Epysqli contains the active substance eculizumab and it belongs to a
class of medicines called
monoclonal antibodies. Eculizumab binds to and inhibits a specific
protein in the body that causes
inflammation and so prevents your body’s systems from attacking and
destroying vulnerable blood
cells, kidneys, muscles or eye nerves and spinal cord.
_ _
WHAT IS EPYSQLI USED FOR
PAROXYSMAL NOCTURNAL HAEMOGLOBINURIA
Epysqli is used to treat adults and children patients with a certain
type of disease affecting the blood
system called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients
with PNH, their red blood
cells can be destroyed which can lead to low blood counts (anaemia),
tiredness, difficulty in
functioning, pain, dark urine, shortness of breath, and blood clots.
Eculizumab can block the body’s
inflammatory response, and its

خصائص المنتج

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Epysqli 300 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of 30
ml contains 300
mg of eculizumab (10
mg/ml).
After dilution, the final concentration of the solution to be infused
is 5
mg/ml.
Eculizumab is a humanised monoclonal (IgG
2/4κ
) antibody produced in Chinese hamster ovary (CHO)
cell line by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion
Clear, colourless, pH 7.0 solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Epysqli is indicated in adults and children for the treatment of:
-
Paroxysmal nocturnal haemoglobinuria (PNH).
Evidence of clinical benefit is demonstrated in patients with
haemolysis with clinical
symptom(s) indicative of high disease activity, regardless of
transfusion history (see section
5.1).
-
Atypical haemolytic uremic syndrome (aHUS) (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Epysqli must be administered by a healthcare professional and under
the supervision of a physician
experienced in the management of patients with haematological or renal
disorders.
Home infusion may be considered for patients who have tolerated
infusions well in the clinic. The
decision of a patient to receive home infusions should be made after
evaluation and recommendation
from the treating physician. Home infusions should be performed by a
qualified healthcare
professional.
Posology
_Paroxysmal Nocturnal Haemoglobinuria (PNH) in adults _
_ _
The PNH dosing regimen for adult patients (≥ 18 years of age)
consists of a 4-week initial phase
followed by a maintenance phase:
3
•
Initial phase: 600 mg of Epysqli adminis